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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04977232
Other study ID # LYG2021038
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 9, 2021
Est. completion date December 2022

Study information

Verified date July 2022
Source Central South University
Contact Wenbin Guo
Phone +8613875936768
Email guowenbin76@csu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a pilot study using game intervention as an adjuvant treatment, to evaluate the effect of the video game on anhedonia and associated functional change of brain in patients with depression. Participants will be randomized to Experimental group receiving a 8-week treatment of antidepressant drugs and game intervention, or Control group receiving a 8-week treatment of antidepressant drugs. Magnetic resonance imaging scanning and assessment of clinical characteristics and cognitive function were conducted before and after the intervention.


Description:

Depression is a serious mental health problem that affects millions of people globally. Anhedonia, a core symptom of depression, is the loss of pleasure or interest in enjoyable activities. The presence of anhedonia is a risk factor of poor outcome of depression. Although some patients reach remission after treatment, anhedonia still persists as a residual symptom. It is generally believed that the frontal-striatal pathway plays an important role in the reward system of brain in patients with depression. The mechanism of anhedonia is closely related to the function of the brain's reward system dopamine. There have been some research showed benefits of playing video games on brain. Video games can modulate negative emotions and increase positive feelings. Previous studies have confirmed that playing games will activate the release of dopamine in striatum. "Dancing Line" is a commercial music game. Participants need to change the direction of target according to the music by tapping the screen and manage to finish the routes and get the gems along the route as much as possible. Sometimes the view of participants would change during the game. The game is simple for participants to pick up and there is no need for prior gaming experience. The main purpose of the study is to explore the effect of game as an adjuvant treatment on anhedonia, depressive symptoms, cognitive function and associated functional change of brain in patients with depression.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - a diagnosis of Major Depressive Disorder according to DSM IV or V and validated via Mini International Neuropsychiatric Interview (M.I.N.I.) - right handedness - capability of understanding and finishing self-rating scales - capability of providing informed consent Exclusion Criteria: - any other major psychiatric disorders following DSM-5 diagnostic criteria - neurological diseases - a history of drug abuse - suicidal risk - pregnancy - any contraindication for brain MRI scan.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Escitalopram
Selective serotonin reuptake inhibitors (SSRI) were most commonly used first line pharmacotherapy for depression.
Behavioral:
Game intervention
Participants will be instructed to play the commercial video game for about 30-60 minutes at least three times per week.

Locations

Country Name City State
China The Second Xiangya Hospital of Central South University Changsha

Sponsors (1)

Lead Sponsor Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Snaith-Hamilton-Pleasure Scale (SHAPES) Pre-post assessment of anhedonia via the Snaith-Hamilton-Pleasure Scale (SHAPES). Raw score range is 14-56. A higher score indicates a worse outcome. From baseline to 8 weeks
Primary Temporal Experience of Pleasure Scale (TEPS) Pre-post assessment of anhedonia via the Temporal Experience of Pleasure Scale (TEPS). Raw score range is 20-120. A lower score indicates a worse outcome. From baseline to 8 weeks
Primary Hamilton Depression Rating scale (HAMD) Pre-post assessment of depressive symptoms via Hamilton Depression Rating scale (HAMD). Raw score range is 0-52. Higher scores indicate more severe depression. From baseline to 8 weeks
Secondary Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Pre-post assessment of cognitive function via Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). From baseline to 8 weeks
Secondary The Stroop test Pre-post assessment of cognitive function via the Stroop test. From baseline to 8 weeks
Secondary Wisconsin Card Sorting Test (WCST) Pre-post assessment of cognitive function via Wisconsin Card Sorting Test (WCST). From baseline to 8 weeks
Secondary Rumination Responses Scale Pre-post assessment of rumination via Rumination Responses Scale. Raw score range is 22-88. Higher scores indicate worse outcomes. From baseline to 8 weeks
Secondary Magnetic Resonance Imaging data Whole brain Magnetic Resonance Imaging. From baseline to 8 weeks
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